FDA Product Code DQX: Wire, Guide, Catheter
FDA product code DQX covers catheter guidewires used in intravascular procedures.
These thin, flexible wires are inserted into blood vessels to guide catheters, sheaths, and other devices to their target location. They are available in a wide range of diameters, stiffness profiles, and tip shapes optimized for different anatomical access points and clinical applications.
DQX devices are Class II medical devices, regulated under 21 CFR 870.1330 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..
764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
Cleared
Jun 21, 2024
MINAMO blue
Asahi Intecc Co., Ltd.
Cardiovascular
134d
Cleared
Jun 13, 2024
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
FMD Co., Ltd.
Cardiovascular
118d
Cleared
May 24, 2024
PacePro Wire
Opsens, Inc.
Cardiovascular
57d
Cleared
May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle
Cardiovascular
257d
Cleared
Oct 28, 2023
Mighty Wire Guide Wire
Merit Medical Systems, Inc.
Cardiovascular
254d
Cleared
Oct 24, 2023
Steerant™ Super Stiff Guidewire
Medtronic Vascular
Cardiovascular
61d
Cleared
Oct 11, 2023
VASSALLO GT Crossing14
Filmec Co. , Ltd.
Cardiovascular
47d
Cleared
Oct 11, 2023
VASSALLO GT 018 G12
Filmec Co. , Ltd.
Cardiovascular
47d
Cleared
Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
Asahi Intecc Co., Ltd.
Cardiovascular
157d
Cleared
Jul 14, 2023
TalWire
Embrace Medical , Ltd.
Cardiovascular
207d
Cleared
May 05, 2023
Wattson temporary pacing guidewire (2250)
Vascular Solutions, LLC
Cardiovascular
59d
Cleared
Apr 28, 2023
BNLE Access Guidewire
Biomerics Nle
Cardiovascular
350d
Cleared
Mar 09, 2023
Vassallo GT 018 Hybrid
Filmecc Co., Ltd.
Cardiovascular
115d
Cleared
Mar 01, 2023
ProTrack Pigtail Wire
Baylis Medical Company, Inc.
Cardiovascular
442d
Cleared
Dec 19, 2022
Mechanical Guidewire
Baylis Medical Company, Inc.
Cardiovascular
223d
Cleared
Oct 26, 2022
VASSALLO GT EXT
Filmecc Co., Ltd.
Cardiovascular
56d
Cleared
Oct 07, 2022
Pre-Formed Blue
Lake Region Medical
Cardiovascular
128d
Cleared
Sep 21, 2022
EpiFaith CV
Flat Medical Co., Ltd.
Cardiovascular
399d
Cleared
Sep 14, 2022
SavvyWire
Opsens, Inc.
Cardiovascular
278d
Cleared
Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
Asahi Intecc Co., Ltd.
Cardiovascular
270d
Cleared
Aug 19, 2022
Stent Positioning Assistance System (SPAS)
Seven Sons , Ltd.
Cardiovascular
50d
Cleared
Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
Asahi Intecc Co., Ltd.
Cardiovascular
270d
Cleared
Jun 30, 2022
VASSALLO GT 018 Floppy
Filmecc Co., Ltd.
Cardiovascular
195d
Cleared
May 27, 2022
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FMD Co., Ltd.
Cardiovascular
311d